G1 Therapeutics experiences a 9.3% jump in stock price due to takeover speculation, following reports of rejected approaches
https://seekingalpha.com/news/4103747-g1-therapeutics-jumps-amid-takeover-speculation
Thursday, May 9, 2024
Embecta Q1 beats, increased guidance as insulin pump tech progresses
Embecta (Nasdaq:EMBC) shares got a massive boost today on first-quarter results that came in well ahead of the consensus forecast.
Shares of EMBC rose nearly 40% to $14.17 apiece in late-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.7%.
The Parsippany-based BD diabetes spinoff reported profits of $28.9 million. That equals 50¢ per share on sales of $287.2 million for the quarter ended March 31, 2024.
Embecta more than doubled its profits on a sales uptick of 3.6%.
Adjusted to exclude one-time items, earnings per share came in at 67¢. That landed 27¢ ahead of expectations on Wall Street. Sales also landed well ahead of the forecast as experts estimated $264.7 million in revenue.
Devdatt (Dev) Kurdikar, CEO of Embecta, said in a news release that the company continued to progress on several fronts, including progress with its open-loop insulin patch pump technology that remains under FDA review. Its closed-loop insulin delivery system for type 2 diabetes, which has FDA breakthrough device designation, continues to move forward, too.
“Our performance in the second quarter and fiscal first half of 2024 underscores the resiliency of our base business, as well as strong operational execution by our global team,” Kurdikar said. “Since our spinoff approximately two years ago, we’ve remained steadfast in delivering on our financial and strategic priorities, including standing Embecta up as an independent company; maintaining stability within our core injection business; and investing in growth, most notably behind our insulin patch pump.”
Embecta raised the low end of its guidance range for 2024, now projecting revenues between $1.111 billion and $1.116 billion. It raised its adjusted EPS forecast from between $1.95 and $2.15 to between $2.20 and $2.30.
Analysts remain neutral on Embecta as they await more information on the coming developments.
“We acknowledge a lack of visibility into the timing and investments needed to build a manufacturing and commercial infrastructure for the planned Type 2 patch pump,” said BTIG’s Marie Thibault and Sam Eiber.
https://www.drugdeliverybusiness.com/embecta-stock-skyrockets-guidance-q1-2024/
Merck Keytruda Strikes Out Again in Endometrial Cancer with Phase III Flop
Merck’s Keytruda swung and missed in endometrial cancer for the second time in six months. Thursday, the pharma giant announced that its bestseller flopped in a Phase III trial in high-risk disease.
Used as an adjuvant treatment with chemotherapy, with or without radiotherapy for newly diagnosed high-risk patients, the anti-PD-1 treatment did not meet the primary endpoint of disease-free survival compared to placebo at the interim analysis.
Keytruda already holds two approvals in specified types of endometrial cancer—in combination with Eisai’s Lenvima for advanced, inoperable endometrial carcinoma that has progressed after therapy and as a single agent in similarly diagnosed patients. Merck also has an ongoing development program testing Keytruda in combination with chemotherapy and as a single agent in specified patient populations.
In December 2023, the Keytruda-Lenvima combination failed to improve survival in patients with advanced or recurrent endometrial carcinoma.
That announcement came on the heels of back-to-back Keytruda flops in non-small cell lung cancer (NSCLC). In December, the company announced that combined with its experimental anti-TIGIT antibody vibostolimab, the anti-PD1 failed to improve progression free survival in NSCLC patients. The same day, a trial of Keytruda plus AstraZeneca’s Lynparza failed to elicit significant improvement in overall survival in metastatic squamous NSCLC. Then, in March, the company announced that the Lynparza combination fell short of dual primary endpoints in specific patients with metastatic non-squamous NSCLC.
Despite the recent disappointments, Keytruda is still raking in top sales for Merck. The blockbuster immunotherapy has racked up over 30 indications since its 2014 approval in advanced melanoma patients with a BRAF mutation.
In April, Merck reported a 20% jump in Keytruda sales for the first quarter of 2024 compared to the same period last year. The treatment brought in $6.9 billion for the quarter, accounting for nearly half of Merck’s $14 billion total pharmaceutical sales. Analysts anticipate Keytruda will top $30 billion in annual sales by 2026 before falling off the patent cliff as biosimilars hit the market as soon as 2028.
Takeda Lowers Profit Outlook Amid Vyvanse Loss of Exclusivity, Eyes $900M Restructuring in 2024
Takeda on Thursday released the business report for its 2023 fiscal year, touting a modest increase in annual revenue while forecasting a profit hit for the coming year tied to the continued sales erosion of its ADHD therapy Vyvanse (lisdexamfetamine dimesylate).
For the fiscal year that ended March 31, 2024, Takeda booked more than $27 billion in revenue. This figure represents a 1.5% increase at constant exchange rates from its fiscal year 2023 revenue of $25.8 billion. Despite the revenue bump, Takeda’s net profit for the year dropped 57% to $925 million, from approximately $2 billion during the previous fiscal year.
Takeda’s reported operating profit likewise took a 50.3% hit, dropping from $3.15 billion to $1.37 billion in the fiscal year 2023.
According to the pharma’s investor presentation, the drop in reported operating profit could be attributed to higher operating expenditure as well as “impairments” with its Crohn’s disease stem cell therapy Alofisel (darvadstrocel) and lung cancer tyrosine kinase inhibitor Exkivity (mobocertinib).
In October 2023, Alofisel failed its Phase III ADMIRE-CD II study, unable to significantly improve 24-week combined remission in patients with complex Crohn’s perianal fistulas. The company subsequently decided not to file for regulatory approval in the U.S., according to its presentation on Thursday. The same month, Takeda withdrew Exkivitiy globally after it failed the confirmatory Phase III EXCLAIM-2 study.
Looking ahead to the rest of the current fiscal year, Takeda tempered investor expectations and lowered its core operating profit guidance by approximately 10%. The Japanese multinational now anticipates booking around $6.4 million (or ¥1 billion) in the coming year. Takeda’s forecast also includes a “flat to slightly declining” annual revenue.
This annual guidance reflects the continued sales erosion that Takeda is expecting to weather as generic versions of its ADHD medicine Vyvanse hit the market. First approved in 2003, Vyvanse lost several crucial patent protections in 2023, including those that covered adult indications in February, and those for pediatric use in August. There are at least 12 impending generic version of Vyvanse from companies such as Sandoz, Teva and Mylan.
Takeda has lined up several upcoming pipeline milestones to make up for Vyvanse’s loss of exclusivity. In the coming fiscal year, for instance, it is planning to launch a Phase III study of its tyrosine kinase 2 inhibitor zasocitinib in psoriatic arthritis, as well as a head-to-head study versus BMS’s Sotyktu (deucravacitinib) in psoriasis.
The pharma is also awaiting a Phase III readout for its cholesterol 24-hydroxylase inhibitor soticlestat in the first half of the fiscal year. The drug candidate is being studied for Dravet syndrome or Lennox-Gastaut syndrome, two rare epileptic conditions.
Aside from its promising pipeline, Takeda will also implement an “enterprise-wide efficiency program,” which will start in fiscal year 2024, according to its business report. The pharma expects this strategic initiative to cost nearly $900 million.
Novo Inks $600M Deal with Metaphore to Develop Next-Gen Obesity Drugs
Novo Nordisk on Thursday entered into a research collaboration agreement with the Flagship-founded Metaphore Biotechnologies to develop up to two next-generation GLP-1 receptor agonists for the treatment of obesity.
As per the terms of the deal, Novo will hand over up to $600 million in upfront, development and commercial milestone payments, and will reimburse R&D costs. In addition, Metaphore will be eligible for tiered royalties on annual sales of approved products that come out of the collaboration. The Danish pharma has also agreed to participate in a future financing round that Metaphore holds.
In return, Novo will gain access to Metaphore’s proprietary MIMIC platform, which can copy the interactions between molecules, to develop multitarget investigational therapeutics that can activate the GLP-1 receptor and affect related pathways, according to Thursday’s news release. These candidates will be designed to have scalable, long-acting effects.
Metaphore’s MIMIC platform will support the development of these next-generation GLP-1 candidates by creating high-resolution maps of what the biotech calls the “pharmacophore,” or the essential features of a molecule that can kick off a specific cascade. MIMIC then uses these pharmacophores as bases for novel therapeutic candidates, whose characteristics can in turn be fine-tuned. For instance, MIMIC-designed compounds can have better specificity and selectivity for their target or have multiple affinities, longer half-lives and other similar functionalities, according to Metaphore.
Uli Stilz, head of the Novo Nordisk Bio Innovation Hub, said in a statement that Metaphore’s MIMIC technology has “impressive accuracy” at capturing the natural dynamics between molecules at their point of interface, “potentially leading to therapeutics that require infrequent dosing.” Thursday’s deal will allow Novo to also apply a machine learning approach to obesity management, Stilz added.
Leveraging the power of AI might also help Novo retain its dominance in the lucrative obesity market, particularly as its main competitor Eli Lilly closes in. In March 2024, Reuters reported that Lilly’s weight-loss drug Zepbound—which is also a GLP-1 agonist but additionally targets the GIP receptor—surpassed Novo’s Wegovy in new prescriptions in the U.S.
Aside from the growing market share of Wegovy, Lilly is also leading the industry in terms of oral GLP-1 treatments, with its small molecule drug candidate orforglipron currently in Phase III. Mid-stage data released in June 2023 underscored orforglipron’s strong potential, reducing body weight by between 9.4% and 14.7% at 36 weeks versus placebo’s 2.3%.In its full-year 2023 business report, the pharma announced that it was already ramping up manufacturing capacity for the oral candidate.
Biden Accused Of Helping Hamas As Israelis Fume Over Threat To Halt Weapons
Israeli leaders are furious after the evening prior CNN published an interview with President Biden wherein he laid out that the US will withhold all offensive weapons from Israel if it moves forward with a full-scale invasion of Rafah.
In a message to both Israel's "enemies and best friends" - clearly a reference to Washington - Defense Minister Yoav Gallant on Thursday vowed that Israel "will achieve [its] goals in the north and south."
"I say from here to Israel’s enemies and its best friends: The State of Israel cannot be subdued — not the IDF, not the Defense Ministry, not the defense establishment, not the State of Israel. We will stand, we will achieve our goals, we will hit Hamas, we will destroy Hezbollah, and we will bring security," Gallant said.
"Whatever the cost, we will ensure the existence of the State of Israel and remember well the directive we signed just a week ago during the Holocaust Remembrance Day ceremony, the words ‘Never Again.’ For me, it’s not just a directive, it’s a work plan. This is how the defense establishment will work and this is how the IDF will work," he added.
"We have no choice, we have no other country. We will do whatever is necessary, and I repeat – whatever is necessary, in order to defend the citizens of Israel, to remove the evil threats against us, and to stand up to those who attempt to destroy us."
Prime Minister Benjamin Netanyahu also responded, but just as with Gallant he has not named Biden or the United States directly...
But others were more blunt and direct, claiming that Biden with this move is 'helping Hamas':
Finance Minister Bezalel Smotrich stated bluntly that the strong American opposition would only reinvigorate Israel’s drive to eliminate Hamas.
“We must continue this war until victory, despite, and to a certain extent precisely because of, the opposition of the administration Biden and the stopping of arms shipments,” he said in a statement. “We simply have no other choice that does not endanger our existence and security.”
National Security Minister Itamar Ben Gvir, a firebrand who leads the far-right Otzma Yehudit party, tweeted simply that “Hamas [loves] Biden.”
Here's what the hardline and hawkish national security minister tweeted out:
Former President Donald Trump agreed, writing in a statement that Biden withholding defense deliveries is tantamount to siding with the terrorists.
Part of his message also included the words "Biden is weak, corrupt, and leading the world straight into World War III. Remember - this war in Israel, just like the war in Ukraine, would have NEVER started if I was in the White House. But very soon, we will be back, and once again demanding PEACE THROUGH STRENGTH!"
The Rafah mission appears to still be on, and Israel's message of defiance in response to Biden let that be known. Meanwhile Israel's Walla News is reporting that the Hamas delegation has now left Cairo and that there has been no ceasefire breakthrough, with both sides once again blaming the other for rejecting a deal.
Israel has previously warned that Israel would give Hamas one week to accept the latest deal on the table (and that warning was issued last week), or else the military would go into Rafah. The refugee-packed southern city of the Gaza Strip has in the last hours been getting hammered by airstrikes, as tens of thousands of civilians scramble to get out.
Biden had said controversially in the CNN interview which angered the Israelis, "I’ve made it clear to Bibi (Prime Minister Benjamin Netanyahu) and the war cabinet: They’re not going to get our support if they go [into] these population centers."
"Civilians have been killed in Gaza as a consequence of those bombs and other ways in which they go after population centers," Biden said. "I made it clear that if they go into Rafah — they haven’t gone in Rafah yet — if they go into Rafah, I’m not supplying the weapons that have been used historically to deal with Rafah, to deal with the cities — that deal with that problem."
"We’re going to continue to make sure Israel is secure in terms of Iron Dome and their ability to respond to attacks that came out of the Middle East recently," Biden continued before spelling out: "But it’s, it’s just wrong. We’re not going to — we’re not going to supply the weapons and artillery shells."
Biden is now getting pushback at home too, with Congressional leaders demanding answers as to why Washington's close Mideast ally is being threatened with the withholding of vital US defense aid...
"This news flies in the face of assurances provided regarding the timely delivery of security assistance to Israel," House Speaker Mike Johnson (R-La.) and Senate Minority Leader Mitch McConnell (R-Ky.) wrote Biden in a letter issued Wednesday.
"The American public deserves to understand the nature, timing, and scope of these reviews," they wrote, and added that "daylight between the United States and Israel at this dangerous time risks emboldening Israel's enemies and undermining the trust that other allies and partners have in the United States."
Neuralink faces problems with first implant ever installed in human brain
Elon Musk's neurotechnology startup Neuralink has said it has experienced a problem with its brain-computer interface that was surgically implanted into its first ever human patient earlier this year.
In March, Neuralink implanted its technology, which lets users control computer cursors with their minds, into the brain of 29-year-old Noland Arbaugh, who was paralyzed from the shoulders down in a driving accident in 2016.
Neuralink's N1 brain-computer interface uses 64 threads, that contain a combined sum of 1,024 electrodes, to pick up on neural activity in the brain and translate that information into cursor movements.
In a blog post, Neuralink has, however, said that "a number" of the 64 threads that connect the implant to Arbaugh's brain subsequently "retracted" in the weeks following the surgery, leading to a reduction in the amount of information it could pick up.
This led to a "net decrease in the number of effective electrodes" connected to Arbaugh's brain and reduced the "speed and accuracy" with which the former college athlete was able to control the cursor via Neuralink's interface.
In response, Neuralink modified its algorithm to increase its sensitivity and make it more responsive to the signals it was receiving, leading to "rapid and sustained improvements" in Noland's ability to use the cursor.
The Fremont, California company's brain computer interface has enabled Arbaugh to browse the internet and play various computer games, including online chess, Civilization VI, and Mario Kart, using only his brain. Arbaugh previously used a stylus held in his mouth.
Neuralink's blog post was posted online following an inquiry from the Wall Street Journal, the newspaper said. The Wall Street Journal reported the problems could have been caused by air trapped inside Arbaugh's brain, citing people familiar with the situation.
The startup, which was launched by Musk in 2016 having hired an array of high-profile neuroscientists, is now planning to install its N1 implant into the brains of 10 more patients this year, the Wall Street Journal said.
The company has also told the U.S. Food and Drug Administration that it believes it has a solution to the problems with Arbaugh's implant, the newspaper reported.
Neuralink and the U.S. FDA were approached by MarketWatch for comment.
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